510K L3/4 TUV CE Sterile Surgical suits By Guangzhou King Yon Medical Tech Co., Ltd, Others1
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510K L3/4 TUV CE Sterile Surgical suits

510K L3/4 TUV CE Sterile Surgical suits

FOB Price

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Minimum Order

Localité:

-

Prix de commande minimale:

-

Commande minimale:

50000 Piece

Packaging Detail:

as per attach photo or brochure

Delivery Time:

As per cutomer requirements

Supplying Ability:

300000 Piece per Day

Payment Type:

T/T

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Guangzhou King Yon Medical Tech Co., Ltd

Guangzhou King Yon Medical Tech Co., Ltd

Others1

Membre gratuit

Personne à contacter Mr. Sam

Room 302C, No.718, Blv San Yuan Li, Bai Yuan District,, Changping, Guangdong

Contacter maintenant

Description

Product Name: Sterile Surgical Suit
Model No.:According to Customer Specification
 
Certificate:
510K No.: K192290
TUV CE Based on EN 13795-1:2019 (CE No.:  G2S 073966 0008 Rev. 01)
TUV Level 4 Test Report from TUV, Based on AAMI PB70:2012
TUV Level 3 Test Report Based on AAMI PB70:2012
TUV Level 2 Test Report Based on AAMI PB70:2012
TUV ISO 13485
 
UMDNS Code:11901
Classification (MDD Annex IX): I Sterile, Rule 1
Conformity Assessment Route:Annex V section 3

General applicable directives:
Medical Device Directive: COUNCIL DIRECTIVE 93/42/EEC
Standard Applied:
 
EN ISO 15223-1:2016    EN1041:2008     EN ISO 13485:2016
EN ISO 14971:2012      EN 13795:2011
Notified Body:TV SD Products Service GmbH, Ridlestr. 65, 80339, Munchen, Germany
Identification Number:0123
(EC) Certificate(S):G2S 073966 0008 Rev.01
Expire Date of the Certificate:2024-05-26
Start of CE Marking:2010-11-26
Place,Date of Issue:Xuchang, 2019-10-15

*Ergonomic fit, enables freedom of movement
*Reinforced
*Breathable and comfortable, suitable for most procedures
*Specially treated to repel low-tension surface fluids
 
Manufacturing Center:10
Sterilization Center: 2
Employee: 4000
RD Center:2
Market: 74 Countries

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